(112 days)
Not Found
No
The device description and intended use clearly describe a standard nitrile examination glove, with no mention of any software, image processing, or AI/ML capabilities. The performance studies are based on physical properties and standards for gloves.
No
The device, a nitrile examination glove, is intended to prevent contamination between patient and examiner and is not designed to treat, cure, mitigate, or prevent disease.
No
Explanation: The device is an examination glove, intended to prevent contamination. It does not perform any diagnostic function.
No
The device is a physical glove made of nitrile, not software. The description details its material, sizes, color, and physical features.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to be worn on the hands of examiner's to prevent contamination between patient and examiner." This is a barrier device for infection control, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical characteristics of a glove (material, size, color, texture) and mentions manufacturing standards for gloves. There is no mention of reagents, calibrators, controls, or any components typically associated with IVD tests.
- Lack of IVD-related information: The document does not mention any of the elements that would be present for an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnostic claims
- Performance metrics relevant to diagnostic accuracy (sensitivity, specificity, etc.)
In summary, the device is a medical glove intended for barrier protection, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
Product codes (comma separated list FDA assigned to the subject device)
LZA
Device Description
The propose device (Mode: NG100) is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are five sizes, includes XS (6.5"), S (7"), M (8"), L (8.5"), XL (9") for optional. The gloves are provided with blue color. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge.
The gloves are manufactured in accordance with the requirements of ASTM D6319-19 and Medical Glove Guidance Manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hands
Indicated Patient Age Range
Not Found
Intended User / Care Setting
examiner's, Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for . Medical Application
- ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions ●
- ASTM D5151-19,Test Method for Detection of Holes in Medical Gloves ●
- ASTM D6124-06(2017), Test Method for Residual Powder on Medical Gloves ●
- ASTM D573-04(2019), Test Method for Rubber-Deterioration in an Air Oven ●
- ASTM D412-16, Test Methods for Vulcanized Rubber and Thermoplastic ● Elastomers-Tension
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For ● In Vitro Cytotoxicity
- . ISO 10993-10: 2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
The test results shows pass the requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
October 12, 2021
Fitone Latex Products Co., Ltd. Guangdong % Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, 555 West Guangzho Shanghai. 200072 China
Re: K211927
Trade/Device Name: Nitrile examination gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Non-Powdered Patient Examination Glove Regulatory Class: Class I, reserved Product Code: LZA Dated: September 7, 2021 Received: September 7, 2021
Dear Stuart Situ:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211927
Device Name Nitrile examination gloves
Indications for Use (Describe)
The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
l. Submitter
Fitone Latex Products Co., Ltd. Guangdong No.5 Huitong road, Lingbei Industrial Zone, Suixi, 524338 Zhanjiang, Guangdong, China
Contact person: Christine Ou Position: Manager Tel.: 0759-7905808 E-mail: market-intl@fitonelatex.com
Preparation date: Jun.11, 2021
US Agent
Qihui Zhang ZYPPEL LLC 1337 Massachusetts Avenue #158 Arlington MA, MA US 02476
II. Proposed Device
| Device Trade Name | Nitrile examination gloves |
|---|---|
| Model | NG100 |
| Common name: | Polymer Patient Examination Glove |
| Regulation Number: | 21 CFR 880.6250 |
| Regulatory Class: | Class I |
| Product code: | LZA |
| Review Panel | General Hospital |
III. Predicate Devices
| 510(k) Number: | K203593 |
|---|---|
| Trade name: | Nitrile examination gloves |
| Common name: | Polymer Patient Examination Glove |
| Classification: | Class I |
| Product Code: | LZA |
| Manufacturer | GUANGDONG KINGFA SCI.&TECH.CO.,LTD. |
IV. Device description
4
The propose device (Mode: NG100) is powder free nitrile examination gloves, provided as non-sterile and disposable device. The proposed devices are blue color and there are five sizes, includes XS (6.5"), S (7"), M (8"), L (8.5"), XL (9") for optional. The gloves are provided with blue color. The examination glove is smooth surface with textured fingertips and a rolled rim at the cuff edge.
The gloves are manufactured in accordance with the requirements of ASTM D6319-19 and Medical Glove Guidance Manual.
V. Indication for use
The nitrile examination glove is intended to be worn on the hands of examiner's to prevent contamination between patient and examiner. This is a single-use, powder-free, non-sterile device.
VI. Comparison of technological characteristics with the predicate devices
| Item | Standard | Proposed device
(K211927) | Predicate device
(K203593) | Discussion |
|-----------------------------------------------------|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Product name | / | Nitrile Examination
Gloves | Nitrile Examination
Gloves | - |
| Product Code | / | LZA | LZA | Same |
| Regulation No. | / | 21 CFR 880.6250 | 21 CFR 880.6250 | Same |
| Classification | / | Class I | Class I | Same |
| Powder free | / | Yes | Yes | Same |
| Indication for
use | / | The nitrile
examination glove is
intended to be worn
on the hands of
examiner's to prevent
contamination
between patient and
examiner. This is a
single-use,
powder-free,
non-sterile device. | The nitrile
examination glove is
intended to be worn
on the hands of
examiner's to prevent
contamination
between patient and
examiner. This is a
single-use,
powder-free,
non-sterile device. | Same |
| Main Material | / | Nitrile rubber | Nitrile rubber | Same |
| Color | / | Blue | Blue | Similar* |
| Size | / | X-small, Medium, large | Small, Large, X large | Similar Dimensions meet ASTM D6319-19 |
| Palm width | ASTM D6319-19 | XS (70±10mm)
S (80±10mm)
M (95±10mm)
L (110±10mm)
XL (120±10mm) | Small (80±10mm)
Medium (95±10mm)
Large (110±10mm)
X large (120±10mm) | Similar Dimensions meet ASTM D6319-19 |
| Length | ASTM D6319-19 | XS (220mm min)
S (220mm min)
M (230mm min)
L (230mm min)
XL (230mm min) | S (220mm min)
M (230mm min)
L (230mm min)
XL (230mm min) | Similar Dimensions meet ASTM D6319-19 |
| Thickness | ASTM D6319-19 | Palm: 0.05mm min
Finger: 0.05mm min | Palm: 0.05mm min
Finger: 0.05mm min | Same |
| Freedom from holes | ASTM D5151-06 | The gloves shall be free from hole when tested in accordance with the method given in ASTM D5151 | The gloves shall be free from hole when tested in accordance with the method given in ASTM D5151 | Same |
| Physical Properties (before aging) | ASTM D6319-19 | Tensile Strength:
14MPa, min
Ultimate Elongation:
500% min | Tensile Strength:
14MPa, min
Ultimate Elongation:
500% min | Same |
| Physical Properties (after aging) | ASTM D6319-19 | Tensile Strength:
14MPa, min
Ultimate Elongation:
400% min | Tensile Strength:
14MPa, min
Ultimate Elongation:
400% min | Same |
| Powder residual | ASTM D6124 | ≤2.0 mg/gloves | | Same |
| Sterility | / | Non-sterile | Non-sterile | Same |
| For single use | / | Yes | Yes | Same |
| Type of use | / | Over the counter use | Over the counter use | Same |
| Shelf-life | / | 3 years | 3 years | The shelf-life testing was |
| | | | | performed
that
demonstrate
meet the
claimed
shelf-life. |
| Biocompatibility
- Skin
Sensitization
Test | ISO
10993-10 | Under the test
condition of study not
an sensitizer | Under the test
condition of study not
an sensitizer | Same |
| Biocompatibility - Skin Irritation
Test | ISO
10993-10 | Under the test
condition of study not
an irritant | Under the test
condition of study not
an irritant | Same |
| Biocompatibility - Cytotoxicity
Test | ISO
10993-5 | Under the test
conditions, the test
article was
non-cytotoxic to L-929
cells. | Cytotoxicity is
assessed via
rationale. Under the
condition of acute
systemic toxicity test,
the test article did not
show acute systemic
toxicity in vivo. | Different |
Table 1 Comparison of Nitrile examination gloves
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6
*As above comparison, the difference in the dimensions and reference standard version of the subject and predicate device does not raise additional questions for safety and effectiveness of the device. The biocompatibility test and performance test of the subject devices have been performed on the final finished device. The test results shows pass the requirements.
VII. Non-Clinical Testing
Non clinical tests were conducted in accordance with following standards to verify that the proposed device met all design specifications.
- ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for . Medical Application
- ASTM D3767-03(2020), Practice for rubber-Measurement of Dimensions ●
- ASTM D5151-19,Test Method for Detection of Holes in Medical Gloves ●
- ASTM D6124-06(2017), Test Method for Residual Powder on Medical Gloves ●
- ASTM D573-04(2019), Test Method for Rubber-Deterioration in an Air Oven ●
- ASTM D412-16, Test Methods for Vulcanized Rubber and Thermoplastic ● Elastomers-Tension
7
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For ● In Vitro Cytotoxicity
- . ISO 10993-10: 2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
VIII. Clinical Testing
No clinical study is included in this submission.
IX. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Nitrile Patient Examination Glove is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K203593.